INVESTIGATIONAL MEDICINAL PRODUCTS. The SPONSOR will supply the investigational medicinal products free-of-charge, including those for comparison and placebos, under the terms provided for in RD 1090/2015. The investigational medicinal product will be supplied via the HOSPITAL’s Pharmacy Service and dispensed on a controlled basis, in accordance with the guidelines in the PROTOCOL. The investigational medicinal product will not be made available to the HOSPITAL or the LEAD INVESTIGATOR until the favorable report from the CEIm and the mandatory authorization from the AEMPS are received.
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